Anesthesia on Optic Nerve Sheath Diameter

Optic Nerve Sheath Diameter Clinical Trial

Official title:

The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diameter in Laparotomic Gynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407715
• Other study ID #: 2018/11-0
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2020
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Different amounts of anesthetic gas can be used in the obstetric gynecological surgery operations to be performed with open method. Researchers aimed to compare the effect of gas changes on intraocular nerve diameter by ultrasonography.

Description:

A total of 80 patients who underwent laparotomic gynecological surgery were divided into two groups prospectively: high flow of 2 L/min and minimal flow of 0.5 L/min. Anesthesia was maintained with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 1 (n=40) and with 50% oxygen-50% air at 2 L/min and desflurane at 1.1 MAC in Group 2 (n=40). After 10-15 minutes, group 2 was administered minimal flow with 50-60% oxygen-40-50% air at 0.5 L/min and desflurane, and 10 minutes before the end of the surgery, the patients were switched to high flow with 50% oxygen-50% air at 2 L/min.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18-65 years

• ASA I-II

• Who underwent laparotomic gynecological surgery

Exclusion Criteria:

• Patients with obstructive pulmonary disease

• Patients with decompensated diabetes, those with a fasting period of more than 12 hours -Acute alcohol intoxication

• Chronic alcohol use

• Who refuse to participate in the study

• Who are not cooperative, do not speak Turkish

• Who had known eye disease (glaucoma, retinal detachment), had a previous history of eye surgery,

• Increased intracranial pressure findings (intracranial lesion, previous cerebrovascular diseases

• Body mass index of > 40kg/m2

• ASA > III

Related Conditions & MeSH terms

• Optic Nerve Sheath Diameter

Intervention

Procedure:
• The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater
The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic Nerve Sheath Diamater	Optic nerve sheath diamater measurements of the patients were recorded before and during the surgery at specified time points (T0: awake, T1: High fresh gas flow after induction at the 10th min., T2: Inhalation anesthesia at the 30th min., T3: Inhalation anesthesia at the 60th min., T4: Inhalation anesthesia at the 90th min., T5: Before extubation).A typical optic nerve sheath is generally less than 5 mm in diameter, and diameters greater than 5.5 mm predict an ICP of =20 cm H2O with 100% sensitivity and specifity	2 hours operation time
Secondary	Peroperative Complications	Complications during the surgery (decreased oxygen levels, hypercapnia, hypotension, hypertension, bradycardia, tachycardia, rhythm disorders) were recorded.	2 hours operation time
Secondary	Postoperative Complications	Complications in the recovery room (respiratory distress, decreased oxygen levels, hypotension, hypertension, bradycardia, tachycardia, vomiting, rhythm disorders) were recorded.	postop 20 minutes